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NCT Number: NCT07698080

Dexamethasone, Intravenous Injection of Human Immunoglobulin, and Increased Infusion of Mononuclear Cells to Reduce Donor Specific Antibodies in Haploidentical Hematopoietic Stem Cell Transplantation

This study tests whether a combination of three treatments - dexamethasone (a steroid), intravenous immunoglobulin (IVIG, a protein that helps the immune system), and an extra dose of donor mononuclear cells - can safely lower harmful antibodies called donor-specific antibodies (DSA) in patients who need a stem cell transplant from a half-matched (haploidentical) family donor.

In these transplants, DSA are antibodies made by the patient's own body that attack the donor's stem cells. If DSA levels are high, the transplant is more likely to fail - the donor cells may not "take" (engraft). Currently, there is no single, simple, and reliable way to reduce DSA, and many existing methods have drawbacks.

Based on the investigators' earlier experience in 11 patients, this three-part approach seemed to work well. All patients successfully engrafted, and DSA levels dropped quickly. Now the study team want to confirm these results in a larger, prospective, multicenter study.

The investigators plan to enroll 60 patients aged 18-65 with blood cancers or other blood disorders who need a haploidentical transplant, have DSA levels above 500 MFI (a measure of antibody strength), and have no other suitable donor available. Participants will receive:

* Dexamethasone (25 mg/m²) for 4 days before transplant, * IVIG (1 g/kg) one day before transplant, * Extra mononuclear cells on transplant day - the extra amount depends on how high their DSA level is (low, medium, or high).

The main goal is to see how many patients have primary graft failure (when the donor cells never engraft). The study team will also measure how long it takes for blood counts to recover, rates of graft-versus-host disease, survival, and side effects. All participants will be followed for 1 year.

This study will help the investigators find out whether this combination is a safe, simple, and effective way to improve transplant success for patients with DSA who have no other donor options.

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Key information

Conditions

Leukemia Anemia Anemia, Aplastic Anemia, Hemolytic Anemia, Hemolytic, Congenital Aplastic Anemia Bone Marrow Diseases Bone Marrow Failure Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemoglobinopathies Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoproliferative Disorders Myelodysplastic Syndromes Neoplasms Neoplasms by Histologic Type Thalassemia

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of benign or malignant hematological diseases (including leukemia, lymphoma, thalassemia, aplastic anemia, myelodysplastic syndromes, etc.) confirmed by NCCN guidelines, and determined by the investigator to require allogeneic hematopoietic stem cell transplantation.
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 3.
  • Donor-specific antibody (DSA) mean fluorescence intensity (MFI) > 500.
  • Age between 18 and 65 years (age limits are also captured separately in the eligibility module).
  • Body weight between 40 kg and 100 kg.
  • No other suitable donor available (i.e., no DSA-negative related donor or unrelated donor).

Exclusion criteria

  • Patients unsuitable for transplantation or without willingness to undergo transplantation, or diagnosed with non-hematological diseases.
  • Estimated life expectancy < 1 month.
  • Known allergy to any drug or intervention used in the study regimen.
  • Pregnancy, lactation, active severe infection, or severe major organ dysfunction.
  • Severe psychiatric or neurological disorders that may affect the ability to provide informed consent and/or to report adverse events or comply with observation.
  • Refusal or inability to sign the informed consent form.

Treatment and study plan

Intravenous immunoglobulin

Biological

1 g/kg intravenously on day -1 prior to transplant.

Dexamethasone

Drug

25 mg/m² intravenously for 4 days prior to transplant (days -4 to -1).

Mononuclear Cells

Biological

Additional donor MNCs infused on day 0. Dose stratified by baseline DSA MFI level: ≤5000: +2±2×10⁸/kg; 5000-10000: +4±2×10⁸/kg; >10000: +6±2×10⁸/kg.

Primary outcomes

  1. Primary Graft Failure (PGF)

    Time frame: Day +28 post-transplant

Secondary outcomes

  1. Neutrophil and Platelet Engraftment Time

    Time frame: Up to 28 days post-transplant

  2. Dynamic Changes in Donor-Specific Antibody (DSA) MFI Levels

    Time frame: Pre-transplant (day -14 to -1) through day +22 post-transplant

  3. Incidence of Acute and Chronic Graft-Versus-Host Disease

    Time frame: Up to 1 year post-transplant

    Cumulative incidence of acute GVHD (aGVHD) graded by standard criteria within 100 days post-transplant, and chronic GVHD (cGVHD) graded by NIH consensus criteria from day +100 through 1 year post-transplant.

  4. Overall Survival and Disease-Free Survival

    Time frame: Up to 1 year post-transplant

    Overall survival (OS) defined as time from transplant to death from any cause. Disease-free survival (DFS) defined as time from transplant to relapse, progression, or death from any cause. Estimated using Kaplan-Meier method at 1 year.

  5. Incidence of Adverse Events

    Time frame: Up to 1 year post-transplant

    Incidence of infectious complications (bacterial, viral, fungal), bleeding events, and other treatment-emergent adverse events. Graded according to CTCAE criteria.

Study contacts

Contact information is provided by the study sponsor or research team.

Sanbin Wang

CONTACT

[email protected]

+8613187424131

Xi Xiong

CONTACT

[email protected]

+8615987422538

Sponsors and collaborators

Lead sponsor

Hematology department of the 920th hospital

Other

Registry information

Official study title

Dexamethasone, Intravenous Injection of Human Immunoglobulin, and Increased Infusion of Mononuclear Cells to Reduce Donor Specific Antibodies in Haploid Hematopoietic Stem Cell Transplantation: a Prospective, Multicenter Study

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jul 13, 2026
Registry last updated
Jul 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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